Associate Director/Senior Manager, Clinical Trial Manager

About Kriya 

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. 

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For” and recognized by Forbes as one of “America’s Best Startup Employers of 2024”.

Who You Are

We are looking for an Associate Director/Senior Clinical Trial Manger for programs within our exciting pipeline. The Associate Director/Senior Clinical Trial Manger will responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites. This position will report to the Vice President of Clinical Operations and work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines, and budgets.

How You Contribute

• Acts as the primary clinical operational oversight to ensure assigned project/studies are conducted in accordance with internal SOPs and ICH GCP requirements. 
• Participate in the preparation of study budgets; negotiation of contracts and vendors; supports invoice review through payment.
• Lead operational activities as they relate to study-level start-up, conduct and close-out.
• Assist with the development of clinical protocols as they relate to the operational aspects of the trial.
• Manage and serve as the main point of contact CRO and other clinical vendors on a study 
• Lead the creation and amending of informed consent forms, source documents, and other documents, manuals and plans related to a clinical trial.
• Participate in the development, maintenance and reporting of clinical project milestones and timelines.
• Participate in the selection of CROs, clinical vendors, and other consultants. 
• Create a partnership with CRO and other key vendors. 
• Establish relationships with PIs and clinical site staff and, in conjunction with the CRO, ensure they are compliant with protocols and overall clinical objectives and deliverables.
• Participate in the creation of the eCRF and data cleaning activities, as necessary.

Additional Essential Responsibilities:

• Lead cross-functional internal study team meetings.
• Work with project management to keep the project plan current and managed to critical path. Provide regular study status updates including critical issues to Program level management as needed.
• Escalates performance issues with CRO and other key vendors in a timely fashion to program level management.
• Collaborate with the Quality Assurance (QA) team to stay abreast of new and/or evolving local regulations, guidelines, and policies.
• Perform other related duties as required to support the Clinical Operations Team and company goals.
• Assist with the development of operational SOPs and processes and contributes to the design of operational excellence activities including study and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.

What You Bring to the Team

Education & Experience

• BS or equivalent
• A minimum 6+ years experience in the pharma/biotech industry with a minimum of at least 4 years direct clinical trials management experience.

Competencies

• Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors).
• Previous clinical trial management or project management experience with demonstrated leadership ability.
• Experience with Electronic Data Capture (EDC), CTMS, IRT systems; UAT experience desirable.
• Excellent communication; interpersonal skills and influencing skills.
• Ability to determine the resources and support to meet project goals and timelines.
• Previous budget and contract negotiation experience.
• Knowledge of ICH/Good Clinical Practices (GCP) 
• Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs.
• Able to work in a fast-paced environment and effectively multi-task.
• Able to work independently.
• Excelle